Legislation and Regulations

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Legislation and Regulations

Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act): An Overview

The goals of the Patient Safety Act are to encourage the expansion of voluntary, provider-driven initiatives to improve the quality and safety of health care; to promote rapid learning about the underlying causes of risks and harms in the delivery of health care; and to share those findings widely, thus speeding the pace of improvement. The Patient Safety Act:

Encourages the development of Patient Safety Organizations (PSOs)—organizations that can work with clinicians and health care organizations to identify, analyze, and reduce the risks and hazards associated with patient care.
Fosters a culture of safety by establishing strong Federal confidentiality and privilege protections for information assembled and developed by provider organizations, physicians, and other clinicians for deliberations and analyses regarding quality and safety.
Accelerates the speed with which solutions can be identified for the risks and hazards associated with patient care by facilitating the aggregation of a sufficient number of events in a protected legal environment.

To read the Patient Safety Act, go to http://www.pso.ahrq.gov/statute/pl109-41.htm

PSO Rulemaking Process

The rulemaking process is designed to achieve consensus within the Federal government. In order to implement the Patient Safety Act, the Department of Health and Human Services (HHS) issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) which became effective on January 19, 2009. To read the Patient Safety Rule, go to: Patient Safety Rule (PDF file, 760 KB. PDF Help).

The Patient Safety Rule establishes a framework by which hospitals, doctors, and other health care providers may voluntarily report information to PSOs, on a privileged and confidential basis, for the aggregation and analysis of patient safety events. In addition, the Patient Safety Rule outlines the requirements that entities must meet to become PSOs and the process by which the HHS Secretary will review and accept certifications and list PSOs. The Patient Safety Rule has the force of Federal law.

The Patient Safety Rule includes a summary of and responses to the Notice of Proposed Rulemaking (NPRM) released by HHS on February 12, 2008. Since the NPRM contains HHS' initial thinking regarding the rule, it provides context for understanding the evolution of the requirements that were incorporated into the Patient Safety Rule. The discussion in the NPRM may be helpful in understanding those provisions of the Patient Safety Rule that were adopted without change from the NPRM. To read the NPRM, go to: NPRM (PDF file, 421 KB (PDF Help).

Additional information:

Press Release for Patient Safety Rule:
Patient Safety Rule Issued for Patient Safety Organizations

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